TEVA-LAMOTRIGINE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LAMOTRIGINE

Boleh didapati daripada:

TEVA CANADA LIMITED

Kod ATC:

N03AX09

INN (Nama Antarabangsa):

LAMOTRIGINE

Dos:

100MG

Borang farmaseutikal:

TABLET

Komposisi:

LAMOTRIGINE 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0127134001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2010-11-12

Ciri produk

PRODUCT MONOGRAPH
PR
TEVA-LAMOTRIGINE
(lamotri
g
ine)
25 mg, 100 mg and 150 mg
Tablets
Antiepileptic
USP
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
Nov 6, 2020
Submission Control No:
245553
TEVA-LAMOTRIGINE Product Monograph Page 2 of 49
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY
PRODUCT
INFORMATION...............................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
........................................................................................
4
ADVERSE
REACTIONS
........................................................................................................
13
DRUG
INTERACTIONS
........................................................................................................
20
DOSAGE
AND
ADMINISTRATION
....................................................................................
26
OVERDOSAGE
......................................................................................................................
30
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................... 30
STORAGE
AND
STABILITY
................................................................................................
34
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .................................................... 34
PART II: SCIENTIFIC INFORMATION
............................................................................
36
PHARMACEUTICAL
INFORMATION
................................................................................
36
CLINICAL
TRIALS
.....................................................................................................